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Disposable skin roller - NMPA Registration 鲁械注准20242201114

Access comprehensive regulatory information for Disposable skin roller in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 鲁械注准20242201114 and owned by Shandong Zhushi Pharmaceutical Group Co., Ltd.. The device was approved on December 25, 2024.

This page provides complete registration details including registrant information, province location (Shandong), intended use, and regulatory compliance data from the official China NMPA medical device database. Pure Global AI offers free access to China's complete medical device registry, helping global MedTech companies navigate NMPA regulations efficiently.

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NMPA Official Data
Class II
鲁械注准20242201114
Disposable skin roller
一次性使用皮肤滚针
NMPA Registration Number: 鲁械注准20242201114
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Intended Use
English

It is used for local stimulation of specific parts of the body surface and needle rolling therapy.

中文

用于体表特定部位的局部刺激，实施滚针疗法。

Device Classification
Device Class
Class II
Model Specifications
0.16mm×0.2mm、0.16mm×0.5mm、0.16mm×1.0mm、0.16mm×1.5mm、0.16mm×2.0mm、0.18mm×0.2mm、0.18mm×0.5mm、0.18mm×1.0mm、0.18mm×1.5mm、0.18mm×2.0mm、0.20mm×0.2mm、0.20mm×0.5mm、0.20mm×1.0mm、0.20mm×1.5mm、0.20mm×2.0mm、0.22mm×0.2mm、0.22mm×0.5mm、0.22mm×1.0mm、0.22mm×1.5mm、0.22mm×2.0mm、0.25mm×0.2mm、0.25mm×0.5mm、0.25mm×1.0mm、0.25mm×1.5mm、0.25mm×2.0mm、0.30mm×0.2mm、0.30mm×0.5mm、0.30mm×1.0mm、0.30mm×1.5mm、0.30mm×2.0mm.
0.16mm×0.2mm、0.16mm×0.5mm、0.16mm×1.0mm、0.16mm×1.5mm、0.16mm×2.0mm、0.18mm×0.2mm、0.18mm×0.5mm、0.18mm×1.0mm、0.18mm×1.5mm、0.18mm×2.0mm、0.20mm×0.2mm、0.20mm×0.5mm、0.20mm×1.0mm、0.20mm×1.5mm、0.20mm×2.0mm、0.22mm×0.2mm、0.22mm×0.5mm、0.22mm×1.0mm、0.22mm×1.5mm、0.22mm×2.0mm、0.25mm×0.2mm、0.25mm×0.5mm、0.25mm×1.0mm、0.25mm×1.5mm、0.25mm×2.0mm、0.30mm×0.2mm、0.30mm×0.5mm、0.30mm×1.0mm、0.30mm×1.5mm、0.30mm×2.0mm。
Approval Department
Shandong Provincial Drug Administration
山东省药品监督管理局
Registration Information
Registration Number
鲁械注准20242201114
Approval Date
December 25, 2024
Expiry Date
December 24, 2029
Registrant
Name
Shandong Zhushi Pharmaceutical Group Co., Ltd.
山东朱氏药业集团有限公司
Province/Region
Shandong
山东
Address
South of Fanlou Road, Shanxian Development Zone
单县开发区樊楼路南
Production Facility
Production Address
山东单县经济技术开发区食品药品产业园单德路6号
Structure and Composition
English

一次性使用皮肤滚针由手柄、支架、轴、滚针、滚轮片、滚轮及保护套组成.其中滚针、轴由O6Cr19Ni10奥氏体不锈钢制成,手柄、支架、滚轮片、滚轮和保护套由聚碳酸酯制成.滚轮片3～9片,直径为20mm.产品经环氧乙烷灭菌,无菌供应.

中文

一次性使用皮肤滚针由手柄、支架、轴、滚针、滚轮片、滚轮及保护套组成。其中滚针、轴由O6Cr19Ni10奥氏体不锈钢制成，手柄、支架、滚轮片、滚轮和保护套由聚碳酸酯制成。滚轮片3～9片，直径为20mm。产品经环氧乙烷灭菌，无菌供应。

Additional Information
Appendix
产品技术要求